Pharmaceutical Commissioning Qualification Validation Engineer - Melbourne, Australia Melbourne / Australia / Full Time CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required. Position Description:
We are now seeking a CQV Engineer to join our growing operations in Australia. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These individuals are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. Responsibilities:
Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns. Experience in planning / directing C&Q activities. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. Familiarity with Baseline Guide 5 (Second Edition) a plus.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience. 2-7 years' experience performing commissioning and/or qualification activities in an FDA regulated industry. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues. High attention to detail. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently, while quickly building and nurturing a project team. Expertise in Microsoft Word and Excel. Excellent oral and written English are required. Able to travel domestically if required. Able to work in Australia without sponsorship.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary. Continuing education (internal and external). Opportunities to work on cutting edge projects in a highly evolving field. Comprehensive Health Insurance coverage aligned with local region regulations. Paid Time Off. ESOP/401K – 15% Company Contribution (US Only). 15% Company Pension Contribution (Europe and APAC Regions). Company Paid Life Assurance. Company Paid Income Protection/Long-Term Disability. Career/Professional Development Opportunities. Additional benefits/leave entitlements based on local regional requirements.
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